RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.

Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.

Dietary Supplement: calcitriol

Given orally

Drug: dexamethasone

Given orally

Experimental: Stage 1, Arm II

No study drugs before surgery.

Other: clinical observation

No intervention before surgery

Experimental: Stage 2, Arm I

Patients receive dexamethasone and calcitriol as in stage 1, arm I.

Dietary Supplement: calcitriol

Given orally

Drug: dexamethasone

Given orally

Experimental: Stage 2, Arm II

Patients receive oral dexamethasone once daily on days 1-4.

Drug: dexamethasone

Given orally

Experimental: Stage 2, Arm III

Patients receive oral calcitriol once daily on days 2-4.

Dietary Supplement: calcitriol

Given orally

Experimental: Stage 2, Arm IV

Patients do not receive study drugs before surgery as in stage 1, arm II.

Other: clinical observation

No intervention before surgery

Detailed Description:

OBJECTIVES:

Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate.

Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients.

Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.

Determine the acute effects of this regimen on serum PSA in these patients.

Determine the toxicity of this regimen in these patients.

OUTLINE: This is a two-stage, randomized, pilot study.

Stage 1: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy.

PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 [10 per treatment arm] and 60 for stage 2) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:

18 Years to 120 Years (Adult, Senior)

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate

Organ-confined disease

cT1, cT2, or cT3 tumors

Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the tumor OR if 50% of the cores examined contain the tumor

No small cell carcinoma of the prostate

Scheduled for radical prostatectomy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Platelet count ≥ 100,000/mm^3

WBC ≥ 3,500/mm^3

Hepatic

ALT and AST ≤ 4 times normal

Bilirubin ≤ 2 mg/dL

Renal

Creatinine ≤ 2 times upper limit of normal

Calcium ≤ 10.5 mg/dL

No detectable renal stones by CT scan or ultrasound

Other

No history of diabetes mellitus requiring pharmacotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 5 years since prior antiestrogens, antiandrogens, luteinizing hormone-releasing hormone agonists, estrogen, or progestational agents

Radiotherapy

Not specified

Surgery

See Disease Characteristics

No prior nephrectomy

No prior prostatic surgery

No prior cryotherapy or transurethral resection of the prostate

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084864